Characterize infections and outcomes developed in relapsed/refractory multiple myeloma (RRMM) patients treated with Teclistamab (SPOT)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  TECVAYLI
• Study drug International non-proprietary name (INN) or common name:
  TECLISTAMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX24) teclistamab

  teclistamab
• Medical condition to be studied:
  Plasma cell myeloma
• Additional medical condition(s):
  Multiple Myeloma

Study design details

• Study design:
  Retrospective, multicenter, observational study
• Main study objective:
  Primary Objective; 1. To describe the incidence, severity, timing, management, and outcomes of infection experienced by patients under Teclistamab treatment in the first 3 months outside of clinical trials; ; Secondary Objectives; 1. To describe the incidence, severity, timing, management, and outcomes of infection experienced by patients under Teclistamab treatment in the first 6 months outside of clinical trials;; 2. To describe the prophylaxis and infections management protocols used in the Portuguese clinical practice;; 3. To describe the differences in baseline characteristics between MM triple-class exposed patients who experienced infections within the first 3 or 6 months of Teclistamab and those who did not;; 4. To describe the overall response rate (partial response or better) and the best response.
• Setting:
  Participating sites will be hospitals with hematology units specialized in treating and managing patients with RRMM in Portugal.